NIH Announces Updated Criteria for Evaluating Research Grant Applications

Notice Number: NOT-OD-05-002

Update: The following update relating to this announcement has been issued:

Key Dates
Release Date: October 12, 2004

Issued by
National Institutes of Health (NIH), (http://www.nih.gov/)

Background

The goal of the NIH Roadmap is to accelerate and strengthen biomedical research enterprise. During consultation with the extramural scientific community that led to the development of the NIH Roadmap process, it was frequently mentioned that the criteria used to evaluate research grant applications were not placing appropriate emphasis on some important types of biomedical research (see http://nihroadmap.nih.gov/). The Roadmap Trans-NIH Clinical Research Workforce Committee proposed a modification of the NIH Peer Review Criteria for investigator-initiated research grant applications that would better accommodate interdisciplinary, translational, and clinical projects. The updated review criteria were adopted at the August 5, 2004 meeting of the Directors of the NIH Institutes and Centers. According to the schedule shown below, the updated criteria will replace the review criteria adopted on June 27,1997 (see http://grants.nih.gov/grants/guide/notice-files/not97-010.html).

Implementation

These updated review criteria will be effective for research grant applications received on or after January 10, 2005 that fall into the following categories:

Note: RFAs published before this announcement will continue to use the existing review criteria. RFAs published after this announcement will use the newly updated criteria (shown below) as a framework for the development of review criteria specific to the RFA.

Beginning with reviews in the summer of 2005, reviewers will be instructed to use the updated review criteria (shown below) as the basis for evaluating research grant applications and for assigning a single, global score for each scored application. The score should reflect the overall impact that the project could have on the advancement of science. The emphasis on each criterion may vary from one application to another; and an application need not be strong in all categories to be judged likely to have a major scientific impact.

Future RFAs and PAs, which will be published in the NIH Guide to Grants and Contracts, will incorporate and employ these updated criteria as the basis for evaluating all research applications.

Updated NIH Criteria for the Evaluation of All Research Applications

The goals of NIH'supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

1. Significance . Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach . Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation . Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators . Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. Environment . Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

NOTE: Requests for Applications (RFAs), which are published in the NIH Guide to Grants and Contracts, may list additional elements, relating to the specific requirement of the RFA, under each of the above criteria. Additional Review Criteria: In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Inquiries

For more information, including a side by side description of the changes, and frequently asked questions, see the OER: Peer Review Policy and Issues website (http://grants.nih.gov/grants/peer/peer.htm#documents).

Feedback and comments regarding the criteria may be left at [email protected].

Inquiries regarding this notice may also be directed to:

Anthony M. Coelho, Jr., Ph.D.
Review Policy Officer
OD/OER/OEP
National Institutes of Health
6701 Rockledge Drive, Room 3533
Bethesda, MD 20892
Telephone: (301) 402-7543
Email: [email protected]


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